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Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting
Investigational ZORYVE® (roflumilast) cream 0.05% was well tolerated with safety findings consistent with prior pediatric experience in the INTEGUMENT
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":" Investigational ZORYVE® (roflumilast) cream 0.05% was well tolerated with safety findings consistent with prior pediatric experience in the INTEGUMENT programZORYVE cream improved signs and symptoms of mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months over four weeksCaregivers reported rapid improvement in itch in as little as 10 minutes in nearly half of infantsResults from additional studies across the ZORYVE portfolio being presented in three poster presentations WESTLAKE VILLAGE, Calif. and DENVER, March 28, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new data from the INTEGUMENT-INFANT Phase 2 trial demonstrating that ZORYVE® (roflumilast) cream 0.05% reduced signs and symptoms of atopic dermatitis, the most common form of eczema, in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis. These results build upon the topline results announced last month and further support the potential of investigational ZORYVE cream as a treatment option for this youngest and very vulnerable population. The results were presented today during a late-breaking podium presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO. “Infantile atopic dermatitis presents daily challenges for affected patients and their families, and clinicians have limited topical options to treat it,” said Lawrence F. Eichenfield, MD, of Rady Children’s Hospital San Diego and the University of California San Diego School of Medicine, and presenting author of the INTEGUMENT‑INFANT data. “The rashes and itch of eczema result in disrupted sleep and significant distress for both infants and their families. In this Phase 2 study, once‑daily ZORYVE cream 0.05% provided meaningful improvements in severity of the signs and symptoms of disease over four weeks, with caregivers reporting rapid relief of itch in as little as 10 minutes. The study results show that ZORYVE cream was effective with a safe and well-tolerated profile in infants down to 3 months of age.” The INTEGUMENT-INFANT open-label trial evaluated the safety and tolerability of once-daily ZORYVE cream 0.05% in infants (n=101) aged 3 months to less than 24 months...